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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 4721–4740 of 17,755 recalls

Class IITerminated

CALCIUM GLUCONATE 10% INJ (PF), Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

Class IITerminated

MIC 25/50/50MG/ML MDV, Rx only,Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

Class IIOngoing

Chantix (varenicline) tablets 0.5mg/1mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 00069-0471-03. carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42.1 mg tablets.

Pfizer Inc.

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

August 13, 2021 · DrugView details →

Class IITerminated

ASCORBIC ACID (NON-CORN) 500MG/ML SOLN (PF), Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

Class IITerminated

VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

Class IITerminated

METHYLCOBALAMIN 12.5MG/ML MDV INJ SOLN, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

Class IITerminated

PROGESTERONE 100MG/ML MDV OIL INJECTION, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

Class IITerminated

LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

Class IIOngoing

Chantix (varenicline) tablets 1 mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0469-56.

Pfizer Inc.

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

August 13, 2021 · DrugView details →

Class IITerminated

MIC/B12A/B6 15/50/100 5MG/50MG/ML MDV, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

Class IITerminated

Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 mL bottle (NDC 61748-480-30), b) 60 mL bottle (NDC 61748-480-60), Rx only, Manufactured by: Hi-Tech Pharmacal Co. Inc., Amityville,NY 11701

Akorn, Inc.

Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.

August 13, 2021 · DrugView details →

Class IITerminated

ACETYLCYSTEINE 2% OPTH SOLN, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

Class IITerminated

Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0853, NDC 68382-095-05

Zydus Pharmaceuticals (USA) Inc

Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle

August 13, 2021 · DrugView details →

Class IITerminated

LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

Class IITerminated

MIC/B12A 25/50/50MG/ML 1MG/ML MDV, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

Class IITerminated

Pi yen chin Ophthalmic Redness Reliever Drops Made in China, Net Wt.: 10 ml (0.34 fl/oz) Exclusive U.S. Distributor: (Chinese writing)International Nature Nutraceuticals, Inc. New York, NY 10002 www.INNHERB.com. Konzon NDC 51367-008-10

ANHUI WELCOME FOREIGN TRADE CO.,LTD.

Labeling: Not Elsewhere Classified; The packaging states these are ophthalmic drops. However, they are manufactured as nasal drops and sterility cannot be assured.

August 12, 2021 · DrugView details →

Class IITerminated

Naproxen Sodum Tablets USP 220 mg, (Caplet), Manufactured by: Granules India Limited, Sy.No. 160/A, 161/E, 162, &174/A, Gagillapur Village, Dundigal-Gandimalsamma Monday, Medchai-Maikhajgir District - 500043, Telangana, INDIA. NDC 62207-762-36

Granules USA, Inc.

CGMP Deviations

August 11, 2021 · DrugView details →

Class ITerminated

Hydro Pinapple Burn Max Health Thach Dua, packaged in a box containing 20g x 10 goi/sachets, MATXI CORP, UPC 8 936188 880108

Ebay Seller - John Nguyen

Marketed without an approved NDA/ ANDA - presence of undeclared sibutramine

August 11, 2021 · DrugView details →

Class ITerminated

Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903 NDC 70324-326-01

SterRx, LLC

Non-Sterility: firm's third party lab confirmed microbial contamination.

August 10, 2021 · DrugView details →

Class IITerminated

Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903

SterRx, LLC

Lack of Assurance of Sterility

August 10, 2021 · DrugView details →

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